Manufacturing Specialist

Manufacturing Specialist

Hayward, CA

Schedule:

M-F, 7-4 or 8-5

Duration: 6-Month Contract (Potential to Extend)

Pay: $31–36/hr (W2)

Our client is a leading global genomics and biotechnology company specializing in next-generation DNA sequencing technology. They are seeking a Manufacturing Specialist to provide technical and process support to the manufacturing team, helping achieve production plans while maintaining quality and compliance with the client's Quality Systems. Overtime is available on weekends.

• Analyze production data to determine trends and define actions to improve efficiency, product quality and cost
• Identify process discrepancies and collaborate with LCM and Process Engineering for improvement
• Support maintaining the validated state by providing SME support on validation plans, verification and validation protocols, and executing on released protocols
• Act as SME during development and change management on MES and eDHR processes and systems by collaborating with GIS, Process Engineering and Quality
• Support development and, in some cases, create or modify quality documents such as work instructions, procedures, pFMEAs, validation test reports, batch record templates, and test methods
• Proactively participate on continuous improvement teams and projects using Operational Excellence and Lean Six Sigma methodologies
• Participate in the manufacturing internal audit program and assist with corrective actions and audit responses
• Test next generation DNA sequencing instrumentation using released procedures and processes
• Troubleshoot and process non-conformances of products while collaborating with Manufacturing, Quality and Life Cycle Management
• Establish and maintain reports of instrument failures and defects
• Other duties as needed

• High school diploma or GED required; some relevant college-level STEM coursework or training a plus
• Bachelor's degree (BA/BS) in Engineering, Chemistry, Biology, or Physics preferred
• Typically requires no previous technical experience; normally receives detailed instructions on all work

• Strong organizational skills, attention to detail and accuracy, and the ability to work independently within a team environment
• Ability to collaborate on multifunctional teams and manage ambiguity
• Strong interpersonal, verbal, and written communication skills
• Excellent troubleshooting skills required
• Proficiency with Microsoft Office Tools (Excel, Word, PowerPoint)
• Experience with SOPs, DHRs, ECOs, GLP, GMP, and SAP ERP systems is a plus
• Hands-on experience with clinical/diagnostic instrumentation, including DNA sequencing or equivalent, is highly desirable